Spray drier assembly for automated spray drying

ABSTRACT

A spray drier system is provided for spray drying a liquid sample such as blood plasma. The spray drier system may include a spray drier device adapted to couple with a spray drier assembly. The assembly may include an enclosure mounted to a frame. The assembly may receive a flow of drying gas which is directed by the enclosure shape towards a spray drying head mounted within the enclosure to the frame. Flows of a liquid sample may be further received by the head, which aerosolizes the liquid sample. Aerosolized liquid sample and drying air may be mixed within a drying chamber of the enclosure to produce dried sample and humid air. The dried sample and humid air may also be separated in a collection chamber of the enclosure, with the humid air exhausted from the enclosure.

RELATED APPLICATION(S)

This application claims the benefit of priority of U.S. ProvisionalPatent Application No. 61/706,759, filed on Sep. 27, 2012 and entitled,“Automated Spray Drier System, U.S. Provisional Patent Application No.61/820,428, filed on May 7, 2013 and entitled, “Functionally ClosedSystem Equivalence For Aerosoling And Drying Gas,” and U.S. ProvisionalPatent Application No. 61/856,957, filed on Jul. 22, 2013 and entitled,“Spray Drier Assembly For Automated Spray Drying,” the entirety of eachof which is hereby incorporated by reference.

GOVERNMENT SUPPORT

This invention was made with Government support under contractHHSO100201200005C awarded by the Biomedical Advanced Research andDevelopment Authority (BARDA). The Government has certain rights in theinvention.

BACKGROUND

Making up about 55% of the total volume of whole blood, blood plasma isa whole blood component which holds blood cells in suspension. Bloodplasma further contains a mixture of over 700 proteins and additionalsubstances that perform functions necessary for bodily health, includingclotting, protein storage, and electrolytic balance, amongst others.When extracted from whole blood, blood plasma may be employed to replacebodily fluids, antibodies, and clotting factors. Accordingly, bloodplasma is extensively used in medical treatments.

To facilitate storage and transportation of blood plasma until use,plasma is typically preserved by fresh-freezing. Fresh-Frozen bloodPlasma (FFP) is obtained through a series of steps involvingcentrifugation of whole blood to separate plasma and then freezing thecollected plasma within about 8 hours of drawing the whole blood. In theUnited States, the American Association of Blood Banks (AABB) standardfor FFP is up to 12 months from the date of preparation when stored at−18° C. or colder. FFP may also be stored for up to 7 years ifmaintained at −65° C. or colder from preparation until the time at whichit used. In Europe, FFP has a shelf life of only 3 months if stored attemperatures between −18° C. to −25° C., and for up to 36 months ifstored at colder than −25° C. If thawed, European standards dictate thatthe plasma must be transfused immediately or stored at 1° C. to 6° C.and transfused within 24 hours. If stored longer than 24 hours, theplasma must be relabeled for other uses or discarded.

Notably, however, FFP must be kept within a temperature-controlledenvironment throughout its duration of storage to maintain its efficacy,which adds to the cost and difficulty of storage and transport.Furthermore, FFP must be thawed prior to use, resulting in a delay of30-45 minutes before it may be used after removal from cold storage.

Accordingly, there is a need to develop alternative techniques forstorage of plasma.

SUMMARY

In an embodiment, a spray drier assembly is provided for spray drying aliquid sample. The spray drier assembly includes an enclosure having afirst end and a second end and a drying gas inlet adjacent to the firstend adapted to receive a flow of drying gas. The spray drier assemblyfurther includes a spray drying head within the spray dryer assemblyenclosure and positioned within the path of the flow of drying gas. Thespray drying head is adapted to receive a flow of aerosolizing gas and aflow of liquid sample, output an aerosolized flow of liquid sample, andexpose the aerosolized flow of liquid sample to the drying gas passingtherethrough. The spray drier assembly enclosure also includes a dryingchamber positioned between the spray drying head and the second end ofthe enclosure adapted to receive the aerosolized flow of liquid sampleand drying gas and separate the aerosolized flow of liquid sample into adried powder suspended in humid air. The spray drier assembly enclosurealso includes a collection chamber including a first filter adapted toseparate the dried powder from the humid air and an exhaust portallowing the humid air to exit the second end of the enclosure. Thespray drier assembly also includes a second filter, disposed between thedrying gas inlet and the spray drying head.

In an embodiment, the spray drier assembly may further include aremovable drying gas inlet cover that inhibits contaminants fromentering the spray drier assembly through the drying gas inlet. In afurther embodiment, the spray drying head may include a plurality offins, spaced apart by respective openings, where the plurality of finsare adapted to direct the flow of drying gas. The plurality of fins mayextend outwards from a circular nozzle positioned at about the center ofthe spray drying head. The plurality of fins may be oriented at anon-zero angle with respect to a surface normal extending outwards fromthe circular nozzle in the plane of the spray drier head. The pluralityof fins may alternatively or additionally be tilted at an angle suchthat a surface normal to the plane of the fins points out of the planeof the spray drying head.

In an embodiment of the spray drier assembly, the spray drying head maybe adapted to direct the flow of drying gas exiting the spray dryinghead in a helical path.

In an embodiment of the spray drier assembly, the drying gas inlet maybe adapted to receive the flow of drying gas parallel to a longitudinalaxis of the enclosure. In an alternative embodiment, the drying gasinlet may be adapted to receive the flow of drying gas perpendicular toa longitudinal axis of the enclosure.

In an embodiment of the spray drier assembly, the drying gas inlet maybe adapted to receive the flow of drying gas at different rates anddifferent temperatures when it is in fluid communication with the spraydrier device.

In an embodiment, the spray drier assembly may further include a framepositioned within the enclosure and extending from the first end of theenclosure to the second end of the enclosure. The spray drying head maybe attached to the frame adjacent to the first end of the enclosure. Theframe may direct, in part, the flow of the drying gas. The first filtermay be attached to the frame.

In another embodiment, a spray drier assembly is provided for spraydrying a liquid sample. The spray drier assembly may include a spraydrier assembly body enclosing a frame. The frame may define a first bodyportion, a second body portion, and a third body portion, where thefirst and second body portions are separated by a first transition zoneand the second and third body portions separated by a second transitionzone. The spray drier assembly may also include a spray drying headhaving a body. At least a portion of the body may be positioned withinthe first transition zone. The spray drying head is adapted to receive aflow of aerosolizing gas and a flow of liquid sample and output anaerosolized flow of liquid sample. A drying chamber may also bepositioned within the second body portion of the spray drier assemblybody, where the drying chamber is adapted to receive the aerosolizedflow of liquid sample and a drying gas and output dried sample powderand humid air. A collection chamber may also be positioned within thethird body portion of the spray drier assembly body, where thecollection chamber receives the dried powder and humid air in a firstportion and includes a filter adapted to separate the dried powder andhumid air.

In an embodiment of the spray drier assembly, at least one of the flowof drying gas, the flow of aerosolizing gas, and the humid air isadapted to urge the dried powder from the drying chamber to thecollection chamber.

In a further embodiment of the spray drier assembly, the spray drierassembly is adapted for thermal communication with at least one heatsource, where the at least one heat source is positioned outside of thespray drier assembly and wherein the at least one heat source is adaptedto heat the spray drier assembly by electromagnetic radiation. In afurther embodiment, the spray drier assembly is adapted for thermalcommunication with at least two of the heat sources, where the firstheat source heats the drying chamber to a first temperature and thesecond heat source heats the collection chamber to a second temperaturedifferent than the first temperature.

In an embodiment of the spray drier assembly, a width of the frame maydecrease within the first and second transition zones as compared to thefirst, second, and third body portions.

In a further embodiment of the spray drier assembly, the spray dryinghead may further include an outer wall, a center portion, and aplurality of fins extending from the center portion to the outer wall.The plurality of fins may define a plurality of openings extendingthrough the thickness of the spray drying head. In a further embodimentof the spray drier assembly, the center portion of the spray drying headmay be circular and the plurality of fins may extend radially outwardfrom the center portion. The plurality of fins may extend outward fromthe center portion at a non-zero angle with respect to a surface normalextending outward from the center portion in the plane of the spraydrying head.

In a further embodiment of the spray drier assembly, the center portionof the spray drying head includes a first inlet that is adapted toreceive the flow of liquid sample, a second inlet that is adapted toreceive the flow of aerosolizing gas, and an egress port in fluidcommunication with the first inlet and the second inlet. The liquidsample and the aerosolizing gas may contact one another upon exit of theegress port to form the aerosolized flow of liquid sample. In anembodiment, the egress port may be adapted to direct the flow of liquidsample and the flow of aerosolizing gas so as to meet and output theaerosolized flow of liquid sample directed parallel to a longitudinalaxis of the spray drier assembly. In an embodiment, the portions of thespray drying head body including the first and second inlets arepositioned outside of the first transition zone. In a furtherembodiment, the portions of the spray drying head body including thefirst and second inlets are positioned within of the first transitionzone. In an embodiment of the spray drier assembly, the filter may beattached to the frame. The filter may include a frame having first andsecond opposing edges defining an opening, a filter member positionedwithin the opening, a fold which brings the first opposing edges intocontact, and a hermetic joint sealing the contacting first opposingedges together. The second opposing edges define an aperture. Driedpowder and humid air may enter the first filter through the aperture.

In an embodiment of the spray drier assembly, the filter may furtherinclude first reinforcing ribs spanning the lateral distance between thefirst opposing edges and second reinforcing ribs spanning the lateraldistance between the second opposing edges.

In another embodiment, the collection chamber may further include asecond portion, separate from the first portion and in fluidcommunication with the first portion via the filter. The second portionmay further contain a desiccant. The collection chamber may furtherinclude a one-way valve adapted to permit the humid air to exit thecollection chamber. The one-way valve may be adapted for fluidcommunication with a vacuum source for urging the humid air to exit thecollection chamber via the one-way valve. The one-way valve may befurther adapted for fluid communication with a filter possessing aBacterial Filtration Efficiency (BFE) of 10⁶ or more.

In a further embodiment, a spray drier assembly is provided for drying aliquid sample. The spray drier assembly may include a spray drying headpositioned within an enclosure. The spray drying head may be adapted toreceive a flow of aerosolizing gas and a flow of liquid sample andoutput an aerosolized flow of liquid sample. The spray drying head mayinclude an outer wall, a center portion; and a plurality of finsextending from the center portion to the outer wall, the plurality offins defining a plurality of openings extending through the thickness ofthe spray drying head. The spray drier assembly may also include adrying chamber formed within the enclosure and adapted to receive theaerosolized flow of liquid sample and a flow of drying gas from thespray drying head and output dried sample powder and humid air. Thespray drier assembly may also include a collection chamber formed withinthe enclosure, the collection chamber having a integrated filter adaptedto separate the dried powder and humid air.

In an embodiment of the spray drier assembly, the collection chamber mayfurther include an inlet port for receiving the dried powder and humidair, an exhaust port for conveying humid air out of the enclosure, and afirst chamber and a second chamber. The first chamber may be defined bya first wall of the enclosure and a first side of the filter and thesecond chamber may be defined by a second wall of the enclosure and asecond side of the filter. The first chamber may be contiguous with theinlet port and adapted to retain the dried powder and allow transmissionof the humid air to the second chamber through the filter. The secondchamber may be contiguous with the exhaust port.

In an embodiment of the spray drier assembly, at least one of the flowof aerosolizing gas, the flow of drying gas, and the humid air isadapted to urge the dried powder from the drying chamber to thecollection chamber.

In a further embodiment, the spray drier assembly may include a one-wayvalve positioned in the inlet port, the one-way valve permitting flow ofthe humid air and dried powder from the drying chamber to the collectionchamber and inhibiting flow of the humid air and dried powder from thecollection chamber to the drying chamber.

In a further embodiment, the spray drier assembly may include a one-wayvalve positioned in the exhaust port, the one-way valve permitting flowof the humid air from the collection chamber and inhibiting flow of thehumid air into the collection chamber.

In another embodiment, the collection chamber may further include asecond portion, separate from the first portion and in fluidcommunication with the first portion. The second portion may furthercontain a desiccant.

The collection chamber may further include a one-way valve notpositioned at the inlet port or the exhaust port and adapted to permitthe humid air to exit the collection chamber adapted to permit the humidair to exit the collection chamber. The one-way valve may be adapted forfluid communication with a vacuum source for urging the humid air toexit the collection chamber via the one-way valve. The one-way valve maybe further adapted for fluid communication with a filter with aBacterial Filtration Efficiency (BFE) of 10⁶ or more.

In an embodiment of the spray drier assembly, the collection chamber mayfurther include a plurality of spacers adapted to inhibit contactbetween the second side of the filter and the second wall of theenclosure within the collection chamber. The spacers may be selectedfrom the group consisting of ribs and raised bumps.

In a further embodiment, a spray drier assembly is provided for spraydrying a liquid sample. The spray drier assembly may include a spraydrier assembly body having a first end and a second end, a source ofdrying gas in fluid communication with the first end of the spray drierassembly body, and a spray drying head enclosed within the spray dryerassembly body. The spray drying head may include an aerosolizer foraerosolizing a flow of liquid sample received at the spray drying head.The spray drier assembly may be adapted to output the aerosolized flowof liquid sample and expose the aerosolized flow of liquid sample to theflow of drying gas. The spray drier assembly may also include a filter,disposed between the drying gas inlet and the spray drying head and adrying chamber positioned between the spray drying head and the secondend of the spray drier assembly body. The drying chamber may be adaptedto separate the aerosolized flow of liquid sample into a dried samplepowder suspended in humid air. The spray drier assembly may also includea collection chamber having a first filter adapted to separate the driedpowder from the humid air and an exhaust port allowing the humid air toexit the second end of the spray drier body. The spray drier assemblymay additionally include a second filter disposed between the drying gasinlet and the spray drying head.

In an embodiment of the spray drier assembly, the aerosolizer mayprovide ultrasonic waves in a wavelength and frequency sufficient toaerosolize the flow of liquid sample. The aerosolizer may also includeone or more of an ultrasonic atomizing transducer, an ultrasonichumidified transducer, or Piezo ultrasonic atomizer.

In an embodiment of the spray drier assembly, the drying gas may travelin a flow to direct the transfer of dried liquid sample or the humidair. The flow of drying gas may also travel through one or more filtersto remove contaminants from the flow of drying gas.

The spray drier assembly so configured may possess a variety ofadvantages. In one aspect, the frame may provide structural support tothe enclosure and further provide a mechanism for channelling the flowof drying gas through the assembly. In another aspect, one or morefilters may be provided with stand-offs to prevent the enclosure and thefilter member of the filter from contacting one another, beneficiallyinhibiting undesirable pinch-off (i.e., obstruction) of gas flow fromoccurring within the filter. In a further aspect, the spray drierassembly may include a head configured to direct the flow of drying gaswithin a drying chamber of the assembly, increasing the length of theflow path of the aerosolized plasma and drying gas and reducing the timeto dry the plasma for a given chamber size.

In an embodiment, the spray drier assembly may be adapted for thermalcommunication with at least one heat source, wherein the at least oneheat source is positioned outside of the spray drier assembly andwherein the at least one heat source is adapted to heat the spray drierassembly by electromagnetic radiation.

In an embodiment, the spray drier assembly may be adapted for thermalcommunication with at least two of the heat sources, wherein the firstheat source heats the drying chamber to a first temperature and thesecond heat source heats the collection chamber to a second temperaturedifferent than the first temperature.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages will beapparent from the following more particular description of theembodiments, as illustrated in the accompanying drawings in which likereference characters refer to the same parts throughout the differentviews. The drawings are not necessarily to scale, emphasis instead beingplaced upon illustrating the principles of the embodiments.

FIG. 1A is a schematic illustration of an embodiment of a spray driersystem of the present disclosure, including a spray drier device 102 anda spray drier assembly;

FIG. 1B is a schematic illustration of a plurality of the spray driersystems of FIG. 1A for use with a pooled liquid source;

FIGS. 2A and 2B are schematic illustrations of the spray drier assemblyof FIG. 1A;

FIGS. 3A-3B are perspective and cut-away views of embodiments of a spraydrying head of the spray drier assembly of FIGS. 2A-2B;

FIGS. 4A-4B are schematic illustrations of embodiments of additional finconfigurations for embodiments of the spray drier assembly head;

FIGS. 5A-5B are perspective and cut-away views of an alternativeembodiment of the spray drier assembly head;

FIG. 6 is a schematic illustration of an alternative nozzle for thespray drier assembly head;

FIG. 7A-7B are schematic illustrations detailing embodiments of acollection chamber of the spray drier assembly of FIGS. 2A-2B;

FIGS. 8A-8D are schematic illustrations of an embodiment of a filter ofthe spray drier assembly of FIGS. 2A-2B;

FIG. 8E is a schematic illustration of an alternative embodiment of afilter frame for use in the filter of FIGS. 8A-8D.

FIGS. 9A-9B is a schematic illustration of a first alternativeembodiment of the collection chamber of FIGS. 2A-2B; and

FIGS. 10A-10B is a schematic illustration of a second alternativeembodiment of the filter of the collection chamber of FIGS. 2A-2B.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to systems andmethods for spray drying a liquid sample. In certain embodiments, theliquid sample is plasma obtained from a blood donor. However, it may beunderstood that the disclosed embodiments may be employed to spray dryany mixtures of solid particles in a continuous liquid medium,including, but not limited to, colloids, suspensions, and sols.

In general, a spray drier system is provided for spray drying a liquidsample such as blood plasma. In an embodiment, the spray drier system ofthe present disclosure includes a spray drier device and a spray drierassembly. The spray drier device is adapted, in an aspect, to receiveflows of an aerosolizing gas, a drying gas, and plasma liquid samplefrom respective sources and couple with the spray drier assembly. Thespray drier device may further transmit the received aerosolizing gas,drying gas, and plasma to the spray drier assembly. Spray drying of theplasma is performed in the spray drier assembly under the control of thespray drier device.

In certain embodiments, the spray drier assembly includes a sterile,hermetically sealed enclosure body and a frame to which the enclosurebody is attached. The frame defines first, second, and third portions ofthe assembly, separated by respective transition zones. A drying gasinlet provided within the first portion of the assembly, adjacent to afirst end of the enclosure body.

A spray drying head is further attached to the frame within thetransition zone between the first and second portions of the assembly.This position also lies within the incipient flow path of the drying gaswithin the assembly. During spray drying, the spray drying head receivesflows of an aerosolizing gas and plasma and aerosolizes the plasma withthe aerosolizing gas to form an aerosolized plasma. Drying gasadditionally passes through the spray drying head to mix with theaerosolized plasma within the second portion of the assembly for drying.In the second portion of the assembly, which functions as a dryingchamber, contact between the aerosolized plasma and the drying gascauses moisture to move from the aerosolized plasma to the drying gas,producing dried plasma and humid drying gas.

In alternative embodiments, the aerosolizing gas may be omitted and thespray drier assembly head may include an aerosolizer that receives andatomizes the flow of plasma. Examples of the aerosolizer may include,but are not limited to, ultrasonic atomizing transducers, ultrasonichumidified transducers, and piezo-ultrasonic atomizers. Beneficially,such a configuration eliminates the need for an aerosolizing gas,simplifying the design of the spray drier device and assembly andlowering the cost of the spray drier system.

The spray drying head in an embodiment is adapted to direct the flow ofdrying gas within the drying chamber. For example, the spray drying headincludes openings separated by fins which receive the flow of drying gasfrom the drying gas inlet. The orientation of the fins allows the dryinggas to be directed in selected flow pathways (e.g., helical).Beneficially, by controlling the flow pathway of the drying gas, thepath length over which the drying gas and aerosolized blood plasma arein contact within the drying chamber is increased, reducing the time todry the plasma.

The dried plasma and humid drying gas subsequently flow into the thirdportion of assembly, which houses a collection chamber. In thecollection chamber, the dried plasma is isolated from the humid dryinggas and collected using a filter. For example, the filter in anembodiment is open on one side to receive the flow of humid air anddried plasma and closed on the remaining sides. The humid drying gaspasses through the filter and is exhausted from the spray drierassembly.

In alternative embodiments, the filter is adapted to separate thecollection chamber into two parts. The first part of the collectionchamber is contiguous with the drying chamber and receives the flow ofhumid drying gas and dried plasma. The dried plasma is collected in thisfirst part of the collection chamber, while the humid air passes throughthe filter and is exhausted from the spray drier assembly via an exhaustin fluid communication with the second part of the spray drier assembly.

After collecting the dried plasma, the collection chamber is separatedfrom the spray drier assembly and hermetically sealed. In this manner,the sealed collection chamber is used to store the dried plasma untiluse. The collection chamber includes a plurality of ports allowingaddition of water to the collection chamber for reconstitution of theblood plasma and removal of the reconstituted blood plasma for use. Thecollection chamber is further attached to a sealed vessel containingwater for reconstitution.

When handling transfusion products, such as blood plasma, thetransfusion products must not be exposed to any contaminants duringcollection, storage, and transfusion. Accordingly, the spray drierassembly, in an embodiment, is adapted for reversible coupling with thespray drier device. For example, the spray drier assembly is coupled tothe spray drier device at about the drying gas inlet. Beneficially, soconfigured, the spray drier assembly accommodates repeated or singleuse. For example, in one embodiment, the spray drier assembly and spraydrying head is formed from autoclavable materials (e.g., antibacterialsteels, antibacterial alloys, etc.) that are sterilized prior to eachspray drying operation. In an alternative embodiment, the spray drierhead and spray drying chamber is formed from disposable materials (e.g.,polymers) that are autoclaved prior to each spray drying operation anddisposed of after each spray drying operation.

Reference will now be made to FIG. 1A, which schematically illustratesone embodiment of a spray drier system 100. The system 100 includes aspray drier device 102 configured to receive a spray drier assembly 104.A source of plasma 112, a source of aerosolizing gas 114, and a sourceof drying gas 116 are further in fluid communication with the spraydrier assembly 104. During spray drying operations, a flow of the dryinggas 116A is drawn within the body of the assembly 104. Concurrently, aflow of a blood plasma 112A and a flow of aerosolizing gas 114A are eachdrawn at selected, respective rates, to a spray drying head 104A of theassembly 104. In the spray drier assembly 104, the flow of blood plasma112A is aerosolized in the spray drier head 104A and dried in a dryingchamber 104B, producing a dried plasma that is collected and stored forfuture use in a collection chamber 104C. Waste water 122 removed fromthe blood plasma during the drying process is further collected forappropriate disposal.

The spray drier device 102 further includes a spray drier computingdevice 124. The spray drier computing device 124 is adapted to monitorand control a plurality of process parameters of the spray dryingoperation. The spray drier computing device 124 further includes aplurality of user interfaces. For example, one user interface may allowan operator to input data (e.g. operator information, liquid sampleinformation, dried sample information, etc.), command functions (e.g.,start, stop, etc.). Another user interface may display statusinformation regarding components of the spray drier device (e.g.,operating normally, replace, etc) and/or spray drying processinformation (e.g., ready, in-process, completed, error, etc.).

The spray drier device 102 is in further communication with a Middlewarecontroller 150. The spray drier device 102 records one or moreparameters associated with a spray drying operation. Examples of theseparameters includes, but are not limited to, bibliographic informationregarding the blood plasma which is spray dried (e.g., lot number,collection date, volume, etc.), bibliographic information regarding thespray drying operation (e.g., operator, date of spray drying, serialnumber of the spray drier assembly 104, volume of dried plasma, etc.),process parameters (e.g., flow rates, temperatures, etc.). Uponcompletion of a spray drying operation, the spray drier device 102communicates with the middleware controller to transmit a selectedportion or all the collected information to the middleware controller150.

For example, a spray drying system 100 may be housed in a blood bankfacility. The blood back facility receives regular blood donations forstorage. Liquid plasma is separated from whole blood donations, driedusing the spray drying system 100, and subsequently stored until use.The middleware controller 150 comprises one or more computing devicesmaintained by the blood bank for tracking stored, dried blood.Beneficially, by providing a spray drying system 100 capable of relayinginformation regarding dried plasma to a middleware controller 150 of theblood center in which it is housed, information regarding the storedblood is then automatically conveyed to the blood center.

In an alternative embodiment, illustrated in FIG. 1B, a plurality ofspray drier systems 100A, 100B, . . . 100N can be used in combinationwith a pooled plasma source 112′. In general, the pooled plasma source112′ is a bulk source of blood plasma having a volume larger than oneblood unit, as known in the art (e.g., approximately 1 pint or 450 mL).Two or more of the spray drier systems 100A, 100B, . . . 100N canoperate concurrently, each drawing blood for spray drying from thepooled plasma source 112′, rather than a smaller, local blood source.

The spray drier systems 100A, 100B, . . . 100N in a pooled environmentcan operate under the control of a computing device 124′. The computingdevice 124′ is similar to computing device 124 discussed above, butadapted for concurrent control of each of the spray drier systems 100A,100B, . . . 100N. The spray drier computing device 124′ furthercommunicates with a remote computing device 150, as also discussedabove.

The use of a pooled plasma source 112′, provides advantages over asmaller, local plasma source, such as plasma source 112. When pooledprior to drying, the pooled liquid plasma can be treated for pathogeninactivation with UV light, a chemical, and the like. The pooled liquidplasma is dried using one or more spray drying systems 100 of thepresent invention and then the dried plasma can be collect in a singlecollection chamber or a plurality of collection chambers. If the pooledplasma is dried for human transfusion, then each collection containercan be configured with an attached rehydration solution. If the pooledplasma is to be used for fractionation purposes, then it is collected ina configured without the rehydration solution. Further embodiments of aspray drier device 102 for use with the disclosed spray drier assembly104 may be found in U.S. patent application Ser. No. 13/952,541, filedon Jul. 26, 2013 and entitled “Automated Spray Drier,” the entirety ofwhich is hereby incorporated by reference.

FIGS. 2A and 2B illustrate embodiments of the spray drier assembly 104in greater detail. As illustrated in FIG. 2A, the spray drier assembly104 includes a frame 202. An enclosure or body 204 having first andsecond ends 208A, 208B further extends about and encloses the frame 202.Thus, the body 204 adopts the shape of the frame 202. The enclosure 204may further include a dual layer of film sealed together about theperiphery of the frame 202.

In certain embodiments, the frame 202 may define a first portion 206A, asecond portion 206B, and a third portion 206C of the assembly 104. Thefirst portion of the assembly 206A is positioned adjacent the first end208A of the body 204. The third portion of the assembly 206C ispositioned adjacent to the second end 208B of the enclosure 204. Thesecond portion of the assembly 206B is interposed between the first andthird portions of the assembly 206A, 206C.

The frame 202 further defines first and second transition zones 210A,210B between the first, second, and third portions of the assembly 206A,206B, 206C. For example, the first transition zone 210A may bepositioned between the first and second portions of the assembly 206A,206B and the second transition zone 210B may be positioned between thesecond and third portions of the assembly 206B, 206C. In certainembodiments, the frame 202 may narrow in width, as compared to the widthof the surrounding assembly within the transition zones 210A, and/or210B. The relatively narrow transition zones 210A, 210B help to directthe flow of drying gas 116A through the assembly 202.

In further embodiments, the body 204 may include a drying gas inlet 212,adjacent to the first end 208A. The drying gas inlet 212 may be adaptedto couple with the spray drier device 102 to form a hermetic and sterileconnection that allows the flow of drying gas 116A to enter the assembly104. In one embodiment, illustrated in FIG. 2A, the drying gas inlet 212is positioned within the first portion of the assembly 206A, at aboutthe terminus of the first end of the body 208A. In this configuration,the flow of drying gas 116A is received within the assembly 104 in adirection approximately parallel to a long axis 250 of the assembly 104.

In an alternative embodiment, illustrated in FIG. 2B, the body 204 mayinclude a drying gas inlet 212′. The position of the drying gas inlet212′ is moved with respect to drying gas inlet 212. For example, thedrying gas inlet 212′ may be positioned within the first portion of theassembly 206A and spaced a selected distance from the terminus of thefirst end of the enclosure 208A. In this configuration, the flow ofdrying gas 116A may be received within the assembly 104 in a directionthat is not parallel to the long axis 250 of the assembly 104. Forexample, in a non-limiting embodiment, the flow of drying gas 116A isreceived within the assembly 104 in a direction that is approximatelyperpendicular to the long axis 250 of the assembly 104.

In certain embodiments, the spray drier assembly 104 may further includea removable cover 218. The cover 218 may be employed prior to couplingof the spray drier assembly 104 with the spray drier device 102 in orderto inhibit contaminants from entering the spray drier assembly. Incertain embodiments, the cover 218 may be removed immediately prior tocoupling with the spray drier device 102 or frangible and penetrated bythe spray drier device 102 during coupling with the spray drier assembly104.

The drying gas 116A received by the assembly 104 is urged to travel fromthe first portion 206A, through the second portion 206B, to the thirdportion 206C, where it is removed from the assembly 104. As the dryinggas 116A travels within the first portion of the assembly 206A towardsthe second portion of the assembly 206B, the drying gas 116A passesthrough a first filter 220A which filters the drying gas 116A enteringthe assembly 104 in addition to any filtering taking place within thespray drier device 102 between the drying gas source 116 and the dryinggas inlet 212. In certain embodiments, the first filter 220A is a 0.2micron filter having a minimum BFE of 10⁶. The filter 220A further helpsto ensure the cleanliness of the flow of drying gas 116A.

This process of drying the plasma as it travels through the spray drierassembly 104 may be referred to herein as primary drying. Secondarydrying, which further removes moisture from the dried plasma 230collected within the collection chamber 104C, is discussed in greaterdetail below. In another embodiment, the flows of aerosolizing gas 114Aand/or drying gas 116A used during primary and/or secondary drying canbe supplied by a plurality of heating devices in thermal communicationwith the spray drier assembly 104. Examples of the heating devices mayinclude, but are not limited to, devices that employ energy such aselectromagnetic, radiofrequency, radiation, microwaves for heating. Inthis manner, the plurality of heating devices may emit electro-magneticradiation that passes through the walls of the drying chamber 104B, thecollection chamber 104C, or both for heating the flows of aerosolizinggas 114A and/or drying gas 116A therein.

In an embodiment, during primary drying, the flow of drying gas 116Areceived by the spray drier assembly 104 may possess a temperaturebetween about 50° C. and about 150° C. and a flow rate of between about15 CFM to about 35 CFM. The flow of aerosolizing gas 116A can possess aflow rate of between about 5 L/min and about 20 L/min and a temperaturebetween about 15′C to about 30′C (e.g., 24′C). The flow of liquid sample112A may possess a flow rate of between about 3 ml/min to about 20ml/min. As the plasma is dried, the flow of the aerosolizing gas 114A,the flow of drying gas 116C, or both may direct the flow of the driedsample 230 through at least a portion of the spray drier assembly 104(e.g., the drying chamber, the collection chamber, or both).

In an embodiment, the assembly 104 may further include a spray dryinghead 104A, a drying chamber 104B, and a collection chamber 104C in fluidcommunication with one another. The spray drying head 104A may bemounted to the frame 202 and positioned within the first transition zone210A. So positioned, the spray drying head 104A is also positionedwithin the flow of drying gas 116A traveling from the first portion ofthe assembly 206A to the second portion of the assembly 206B. The spraydrying head 104A may be further adapted to receive the flow of plasma112A and the flow of aerosolizing gas 114A through respective feed lines214, 216 and output aerosolized plasma 230 to the drying chamber 104B.

In further embodiments, the drying chamber 104B and collection chamber104C may be positioned within the second and third portions of theassembly 206B, 206C, respectively. The drying chamber 104B inflatesunder the pressure of the flow of drying gas 116A and provides space forthe aerosolized blood plasma 230 and the flow of drying gas 116A tocontact one another. Within the drying chamber 104B, moisture istransferred from the aerosolized blood plasma 230 to the drying gas 116A(i.e., primary drying), where the drying gas 116A becomes humid dryinggas 234. The aerosolized flow of blood plasma 230 and the flow of dryinggas 116A are further separated, within the drying chamber 104B, intodried plasma 232 and humid drying gas 234. In certain embodiments, thedried plasma 232 may possess a mean diameter of less than or equal to 25μm.

The humid air 234 and dried plasma 232 are further drawn into thecollection chamber 104C through an inlet port 222A of the collectionchamber 104C, positioned within the second transition zone 210B,connecting the collection chamber 104C and the drying chamber 104B. Thecollection chamber 104 includes a second filter 220B which allowsthrough-passage of the humid gas 234 and inhibits through-passage of thedried plasma 232. As a result, the humid gas 234 passing through thefilter 220B is separated from the dried plasma 232 and exhausted fromthe collection bag 104C through an exhaust port 222B of the collectionchamber 104C that forms the second end 208B of the body 204. Forexample, a vacuum source (e.g., a vacuum pump) may be in fluidcommunication with the exhaust port 222B of the collection chamber 104Cto urge the humid gas 234 through exhaust port 222B. Concurrently, thedried plasma 232 is retained in a reservoir 228 of the collectionchamber 104C. The collection chamber 104C is subsequently hermeticallysealed at about the inlet and exhaust ports 222A, 222B, and detached(e.g., cut) from the spray drier assembly 104, allowing the collectionchamber 104C to subsequently function as a storage vessel for the driedplasma 232 until use.

With reference to FIG. 7A, the collection chamber 104C further includesa plurality of one-way valves 702A, 702B positioned at about the inletport 222A and the exhaust port 222B, respectively. The one-way valve702A may function to permit gas flow from the drying chamber 104B to thecollection chamber 104C and inhibit gas flow from the collection chamber104C to the drying chamber 104B. The one-way valve 702B may function topermit gas flow from the collection chamber 104C while inhibiting gasflow into the collection chamber 104C via the exhaust port 222B.

In a further embodiment, if desired, secondary drying can be performedin the collection chamber 104C by maintaining the flow of drying gas116A across the dried plasma 232 once it has been collected in thecollection chamber 104C. In the case of secondary drying, some of theparameters for flow rates and temperatures of the drying gas can bechanged from those specified above for primary drying. For example, theflow of drying gas 116A my possess a temperature between about 35° C.and about 80° C. and a flow rate of between about 10 CFM to about 35CFM. The flow of aerosolizing gas 114A can possess a flow rate ofbetween about 0 L/min and about 20 L/min and a temperature between about15° C. to about 30° C. (e.g., 24° C.).

The collection chamber 104C may be further configured for use inrehydrating the dried plasma 232. For example, the collection chamber104C may include a rehydration port 224, a plurality of spike ports 226,and a vent port 228. The rehydration port 224 may be used to communicatewith a source of rehydration solution, allowing the rehydration solutionto come in contact with the dried plasma 232 within the collectionchamber 104C to form reconstituted plasma. The reconstituted plasma maybe subsequently drawn from the collection chamber 104C through the spikeports 226.

Vent port 228 may adapted to allow venting of the flow of humid dryinggas 234 during secondary drying. For example, in certain embodiments,during primary drying, the vents 702A, 702B may allow for gas flow asdiscussed above and the vent port 228 may be closed. During secondarydrying, after primary drying is completed, the vents 702A, 702B may besealed and the vent port 228 opened. The vent port 228 may be furtherplaced in fluid communication with a vacuum source (e.g., a vacuum pump)for secondary drying. The vacuum source may be In further embodiments, afilter (e.g., 0.22 μm or better) may be inline with the vent port 228.

In yet another embodiment, illustrated in FIG. 7B, a desiccant 710 canbe placed within a pouch or tube 712 of the collection chamber 104C tofacilitate drying. For example, the desiccant or similar substance canbe placed in contact with the dried sample. In another example, thedesiccant or similar substance is not placed in contact with the driedplasma but rather in fluid communication with the dried plasma (e.g., oneither side of the filter within the collection chamber 104C, in aseparate pocket or port). For example, a breakable seal 714 may beinterposed between the pouch and the remainder of the collection chamber104C, allowing a user to bring the desiccant 710 into fluidcommunication with the dried plasma when desired (e.g., after thecollection chamber 104C has been sealed and removed from the spray drierassembly 104). Beneficially, use of desiccant 710 within the collectionchamber 104C may allow for further moisture removal from the driedplasma over the duration of storage and increase the shelf-life of thedried plasma.

The spray drying head 104A will now be discussed in further detail withrespect to the embodiments of FIGS. 3A-3B. A spray drying head 300includes a body 302 having an outer wall 302A and a center portion 302B.The body 302 further includes a plurality of tabs 310 extending outwardsfrom the body 300. The tabs 310 may be adapted secure the spray dryinghead 300 to the frame 202 by a weld or other securing mechanism.

In an embodiment, a plurality of fins 304 extend between the outer wall302A and center portion 302B, defining openings 306 there-between, whichextend through the thickness of the spray drying head 104A. The openings306 provide passageways for drying gas 116A impinging the drying head104A to pass through the drying head 104A. As discussed in greaterdetail below, the plurality of fins 304 may further direct the flow pathof the flow of drying gas 116A into the drying chamber 104B.

In certain embodiments, the outer wall 302A and center portion 302B areconcentric. In further embodiments, the outer wall 302A and centerportion 302B are generally circular. However, it may be understood thatembodiments of the spray drying head 300 may adopt any shape capable ofperforming the functions of the spray drying head 300, as necessary.

The spray drying head 300 is further illustrated in FIG. 3B in cut-away.The center portion 302B includes a nozzle 308 having a plasma inlet 312adapted to couple with the plasma feed line 214 and direct the flow ofplasma to a distal nozzle tip 314. An aerosol gas tubing support 316 isfurther provided for supporting the aerosol feed line 216. The terminusof the aerosol feed line 216 is received at an aerosol gas inlet port320 in communication with an annular opening 322. The flow ofaerosolizing gas 114A passes through the annular opening 322 and exitsthe spray drying head at the distal nozzle tip 314. So configured, theflow of plasma 112A and flow of aerosolizing gas 116A meet as each exitsthe distal nozzle tip 314 to form aerosolized plasma 230. In anembodiment, the aerosolized plasma 230 is directed parallel to the axis250. So configured, the plasma inlet 312 and the aerosol gas inlet port320 may each be positioned within the spray drier assembly body 304.

In certain embodiments, the plurality of fins 304 extend radiallyoutwards from the center portion 302B of the spray drying head 300.FIGS. 4A and 4B illustrate alternative embodiments of configurations ofthe plurality of fins 304. For example, as illustrated in FIG. 4A, theplurality of fins 304 may extend outward from the center of the frame302B at a selected angle α with respect to a surface normal 400extending from the frame center 302B in the plane of the head 300. Incertain embodiments, angle α may range between about 20 degrees to about60 degrees, preferably about 45 degrees. In other embodiments,illustrated in FIG. 4B, the plurality of fins 304 are tilted such that asurface normal 402 to the plane of each of the plurality of fins 304points out of the plane of the spray drying head 300.

By adjusting the orientation of the plurality of fins 304, the spraydrying head 300 modifies the laminar flow of the drying gas 116A passingthere-through to create a helical flow path. The helical flow path maypossess any number of rotations. For example, the drying gas 116A may bedirected in a helical flow path having a selected number of revolutionsthrough the length of the drying chamber 104B (e.g., ¼ revolution, 1revolution, revolutions, 15 revolutions, 25 revolutions, etc.).

Directing the drying gas 116A in a helical flow path is believed toprovide benefits to the spray drying process. For example, in anembodiment the helical flow path may increase the length of contactbetween the spray drying gas 116A and the aerosolized liquid sample 230(e.g., aerosolized blood plasma). The increased length of contact mayreduce the time required to achieve a given level of dryness in theresultant dried plasma 232.

An alternative embodiment of the spray drying head 300 is illustrated inFIGS. 5A-5B. The spray drying head 500 differs from spray drying head300 with the addition of integrated inlet ports for both the flow ofplasma 112A and aerosolizing gas 114A to the spray drying head 500. Thehead body 302 and nozzle 308 remain otherwise unchanged. A plasmamanifold 502 is provided to couple with the plasma feed line 214 todeliver the flow of plasma 112A to the nozzle 308. The plasma manifold502 is further in fluid communication with a plasma port 506. An innerplasma feed line (not shown) connects the plasma port 506 with an innerplasma feed line attachment point 510, similar to plasma inlet 312. Anaerosol manifold 512 is further adapted to communicate with aerosol gasfeed line 216 to deliver the flow of aerosolizing gas 114A to the nozzle308. The flow of aerosolizing gas 114A passes through the annularopening 322 and exits the spray drying head at the distal nozzle tip314. So configured, the flow of plasma 112A and flow of aerosolizing gas116A meet as each exits the distal nozzle tip 314 to form aerosolizedplasma 230. In an embodiment, the aerosolized plasma 230 is directedparallel to the axis 250.

The embodiment of the spray drier head 500 may help to further maintaina sterile environment within the spray drier assembly 104. Connectionpoints, such as the plasma manifold 502 and the aerosolizing gasmanifold 512 provide possible points of entry for contaminants into thespray drying assembly 104. However, in the embodiment of spray drierhead 500, when the head 500 is secured in place to the frame 202, theplasma manifold 502 and the aerosolizing gas manifold 512 are positionedoutside of the first transition zone 210A in a region 260 of the spraydrier body 202. The region 260 of the spray drier body may behermetically sealed from the first, second, and third portions of thespray drier body 206A, 206B, 206C. Accordingly, any contaminants whichcollect on the plasma manifold 502 and the aerosolizing gas manifold 512may be isolated from the flows of liquid sample 112A, aerosolizing gas114A, and drying gas 116A.

. As a result, the need to draw the plasma feed line 214 andaerosolizing gas feed line 216 into the spray drier assembly 104 withinthe first or second portion 206A, 206B may be eliminated. Rather, theplasma feed line 214 and aerosolizing gas feed line 216 may be drawninto the spray drier assembly 104 within a region 260 of the spray drierassembly.

FIG. 6 is a schematic illustration of a further embodiment of a nozzle600 which is adapted to aerosolize a flow of liquid sample 112A withoutuse of an aerosolizing gas. The nozzle 600 includes a channel 602 forconveying the flow of plasma 112A to a distal tip 604 including anultrasonic transducer. The ultrasonic transducer receives electricalinput which is converted into vibratory motion. The transducer may be anultrasonic atomizing transducer, an ultrasonic humidified transducer, ora piezo-electric ultrasonic atomizer. The wavelength and frequency ofthe vibrational motion causes the flow of liquid sample 112A conveyed tothe tip 604 to form standing waves 606. When the vibrational amplitudeof the tip 604 is appropriately selected, the plasma is ripped apartsuch that chunks of fluid, i.e., aerosolized plasma 230, are formed.Beneficially, by removing the need for use of an aerosolizing gas, thespray drying head 104A and spray drier device 102 are simplified,reducing the cost of the spray drier device 102 and assembly 104.

The discussion will now turn to the filters 220A, 220B. In certainembodiments, the filters 220A, 220B may be constructed in the samemanner. One example of a filter bag design which may be employed forboth filters 220A and 220B (collectively 220) is illustrated in FIGS.8A-8D. The filter 220 may include a filter frame 802 having firstopposing edges 804A and second opposing edges 804B. The edges 804A, 804Bmay be contiguous and define an opening 806 (FIG. 8A). A filter member810 may be positioned within the opening 806 and secured to the frame802 (e.g., filter-frame weld zone 812) or other mechanism for forming ahermetic seal between the filter member 810 and the frame 802 along theopposing edges 804A (FIG. 8B). In certain embodiments, the filter member810 may be a 0.2 μm filter having a minimum BFE of 10⁶.

As further illustrated in FIG. 8C, a fold 814 is introduced into theframe 802. In certain embodiments, the fold 814 is positioned atapproximately the middle of a long axis of the frame 808. In otherembodiments, the fold 814 is offset from this midpoint, as necessary.The portions of the frame 802 on each side of the fold 814 are urgedtogether such that the first edges 804A are brought into contact witheach other. The first edges 804A are further hermetically sealedtogether by a weld (e.g., filter-filter weld zone 816) or othermechanism for hermetically sealing surfaces together. The secondopposing edges 804B remain unsealed from each other. This arrangementprovides a filter 220 with a filter mouth 820 adjacent to the secondedges 804B.

When the filter 220 is employed as the first filter 220A, it is mountedto the frame 202 within the first portion of the assembly 206A atsupports 822. The flow of drying gas 116A entering the first portion ofthe assembly 206A from the drying gas inlet 212, enters the filter mouth820 and exit through the filter member 810. Contaminants within the flowof drying gas 116A that are unable to pass through the filter member 810are retained by the filter 220A.

Similarly, when the filter 220 is employed as the second filter 220B, itis mounted to the frame 202 within the third portion of the assembly206C at supports 822. The flow of dried plasma particles 232 and humidgas 234 entering the collection chamber 104C, enter the filter 220Bthrough the mouth 820. The dried plasma particles 232 are inhibited frompassing through the filter member 810, allowing the filter member 810 tostore the dried plasma particles 232 within the reservoir 228 defined bythe fold 814 and sealed, opposing edges 804A of the filter frame 802.

In an alternative embodiment, illustrated in FIG. 8E, the filter 220 isformed from a frame 850. The frame 850 is similar to frame 802 discussedabove, with the addition of a first and second plurality of ribs 852,854 spanning the opening. Beneficially, the first and second pluralityof ribs 852, 854 provide additional support to the filter member 810 andact to inhibit rupture of the filter member 810 during spray dryingoperations.

The first plurality of ribs 852 may span the shortest spaced opposingsides of the frame 850 (e.g., sides 804A), while the second plurality ofribs 854 may span the longest spaced opposing sides of the frame 850(e.g., sides 804B). For example, as illustrated in FIG. 8E, four of thefirst plurality of ribs 852 and one of the second plurality of ribs 854is provided. However, it may be understood that greater or fewer offirst and second plurality of ribs 852, 854 may be employed in the frame850, as necessary. The filter 220 is otherwise formed from frame 850 asdiscussed above with respect to frame 802.

In other embodiments, the filter 222B is different than the filter 220discussed above. In one embodiment, a collection chamber 104C′ employsan inline filter that is introduced parallel to the sidewalls of thecollection chamber 104C′, as illustrated in FIG. 9A-9B. With referenceto the exploded view of FIG. 9A, the collection chamber 104C′ includestwo collection chamber walls 902A, 902B, a filter member 904, and aframe 906. The frame 906 is a portion of the frame 202 and includes anopening 910 dimensioned to receive the filter member 904, where theframe 906 and the filter member 904 are hermetically sealed together.The collection chamber walls 902A, 902B further enclose the frame 906within the collection chamber 104C′ and is hermetically sealed to oneanother about the periphery of the frame 906.

The collection chamber 104C′ so constructed is illustrated incross-section in FIG. 9B. It may be observed that the filter member 904separates the area enclosed by the collection chamber walls 902A, 902Binto two chambers, 920A and 920. The inlet port 222A of the collectionchamber 104C′ is in fluid communication with the chamber 920A. The flowof dried plasma particles 232 and humid drying gas 234 entering thecollection chamber 104C′ flow into the first chamber 920A. Filter member904 inhibits the dried plasma particles 232 from passing through thefirst chamber 920A and into the second chamber 920B, while the humiddrying gas 234 freely passes through the filter 904 into the secondchamber 920B. Accordingly, the dried plasma particles 232 are retainedfor storage within the first chamber 920A, while the humid drying gas234 exits the collection chamber 104C′ via the exhaust port 222B.

FIGS. 10A-10B illustrate alternative embodiments of a collection chamber104C″. The collection chamber 104C″ is adapted to inhibit contactbetween the filter 904 at least one of the collection chamber wall 902Aand the collection chamber wall 902B. With reference to the embodimentof FIG. 10A, the collection chamber 104C″ is similar to collectionchamber 104C′, with the addition of a spacer frame 930 mounted to theframe 906. The spacer frame 930 includes a periphery 932 enclosing theopening 910 and a plurality of ribs 934 spanning the periphery 932. Withreference to FIG. 10B, a plurality of standoffs 936 are secured to thecollection chamber wall 902B and replace the ribs 934. Beneficially,both the ribs 934 and standoffs 936 provide an offset distance betweenthe filter member 904 and collection chamber wall 902B which allows aclear path for airflow between the filter member 904 and exhaust port222B during inflation of the collection chamber 104C″. It may beunderstood that, in alternative embodiments, the ribs 934 and/orstandoffs 936 may be adapted to provide an offset distance between thefilter member 904 and the collection chamber wall 902A, or to provide anoffset distance between the filter member 904 and both the collectionchamber wall 902A and the collection chamber wall 902B.

The terms comprise, include, and/or plural forms of each are open endedand include the listed parts and can include additional parts that arenot listed. And/or is open ended and includes one or more of the listedparts and combinations of the listed parts.

One skilled in the art will realize the invention may be embodied inother specific forms without departing from the spirit or essentialcharacteristics thereof. The foregoing embodiments are therefore to beconsidered in all respects illustrative rather than limiting of theinvention described herein. Scope of the invention is thus indicated bythe appended claims, rather than by the foregoing description, and allchanges that come within the meaning and range of equivalency of theclaims are therefore intended to be embraced therein.

What is claimed is:
 1. A spray drier assembly, comprising: an enclosurehaving a first end and a second end, the enclosure including a dryinggas inlet adjacent to the first end adapted to receive a flow of dryinggas; a spray drying head within the spray dryer assembly enclosure andpositioned within the path of the flow of drying gas, wherein the spraydrying head is adapted to receive a flow of aerosolizing gas and a flowof liquid sample, output an aerosolized flow of liquid sample, andexpose the aerosolized flow of liquid sample to the drying gas passingtherethrough; the spray drier assembly enclosure further including: adrying chamber positioned between the spray drying head and the secondend of the enclosure, the drying chamber adapted to receive theaerosolized flow of liquid sample and drying gas and separate theaerosolized flow of liquid sample into a dried powder suspended in humidair; and a collection chamber including a first filter adapted toseparate the dried powder from the humid air and an exhaust portallowing the humid air to exit the second end of the enclosure; and asecond filter, disposed between the drying gas inlet and the spraydrying head.
 2. The spray drier assembly of claim 1, further comprisinga removable drying gas inlet cover that inhibits contaminants fromentering the spray drier assembly through the drying gas inlet.
 3. Thespray drier assembly of claim 1, wherein the spray drying head includesa plurality of fins, spaced apart by respective openings, wherein theplurality of fins are adapted to direct the flow of drying gas.
 4. Thespray drier assembly of claim 3, wherein the plurality of fins extendoutwards from a circular nozzle positioned at about the center of thespray drying head.
 5. The spray drier assembly of claim 4, wherein theplurality of fins are oriented at a non-zero angle with respect to asurface normal extending outwards from the circular nozzle in the planeof the spray drier head.
 6. The spray drier assembly of claim 4, whereinthe plurality fins are tilted at an angle such that a surface normal tothe plane of the fins points out of the plane of the spray drying head.7. The spray drier assembly of claim 1, wherein spray drying head isadapted to direct the flow of drying gas exiting the spray drying headin a helical path.
 8. The spray drier assembly of claim 1, wherein thedrying gas inlet is adapted to receive the flow of drying gas parallelto a longitudinal axis of the enclosure.
 9. The spray drier assembly ofclaim 1, wherein the drying gas inlet is adapted to receive the flow ofdrying gas perpendicular to a longitudinal axis of the enclosure. 10.The spray drier assembly of claim 1, wherein the drying gas inlet isadapted to receive the flow of drying gas at different rates anddifferent temperatures when it is in fluid communication with the spraydrier device.
 11. The spray drier assembly of claim 1, furthercomprising a frame positioned within the enclosure and extending fromthe first end of the enclosure to the second end of the enclosure. 12.The spray drier assembly of claim 11, wherein the spray drying head isattached to the frame adjacent to the first end of the enclosure. 13.The spray drier assembly of claim 11, wherein the frame directs, inpart, the flow of the drying gas.
 14. The spray drier assembly of claim11, wherein the first filter is attached to the frame.
 15. A spray drierassembly, comprising: a spray drier assembly body enclosing a frame, theframe defining a first body portion, a second body portion, and a thirdbody portion, the first and second body portions separated by a firsttransition zone and the second and third body portions separated by asecond transition zone; a spray drying head having a body, wherein atleast a portion of the spray drying head body is positioned within thefirst transition zone, wherein the spray drying head is adapted toreceive a flow of aerosolizing gas and a flow of liquid sample andoutput an aerosolized flow of liquid sample; a drying chamber positionedwithin the second body portion of the spray drier assembly body, thedrying chamber receiving the aerosolized flow of liquid sample and adrying gas and outputting dried sample powder and humid air; and acollection chamber positioned within the third body portion of the spraydrier assembly body, the collection chamber receiving the dried powderand humid air in a first portion and having a filter adapted to separatethe dried powder and humid air.
 16. The spray drier assembly of claim15, wherein at least one of the flow of drying gas, the flow ofaerosolizing gas, and the humid air is adapted to urge the dried powderfrom the drying chamber to the collection chamber.
 17. The spray drierassembly of claim 15, wherein the spray drier assembly is adapted forthermal communication with at least one heat source, wherein the atleast one heat source is positioned outside of the spray drier assemblyand wherein the at least one heat source is adapted to heat the spraydrier assembly by electromagnetic radiation.
 18. The spray drierassembly of claim 17, wherein the spray drier assembly is adapted forthermal communication with at least two of the heat sources, wherein thefirst heat source heats the drying chamber to a first temperature andthe second heat source heats the collection chamber to a secondtemperature different than the first temperature.
 19. The spray drierassembly of claim 15, wherein a width of the frame decreases within thefirst and second transition zones as compared to the first, second, andthird body portions.
 20. The spray drier assembly of claim 15, the spraydrying head further comprising: an outer wall; a center portion; and aplurality of fins extending from the center portion to the outer wall,the plurality of fins defining a plurality of openings extending throughthe thickness of the spray drying head.
 21. The spray drier assembly ofclaim 20, wherein the center portion of the spray drying head iscircular and wherein plurality of fins extend radially outward from thecenter portion.
 22. The spray drier assembly of claim 20, wherein thecenter portion of the spray drying head is circular and wherein the finsextend outward from the center portion at a non-zero angle with respectto a surface normal extending outward from the center portion in theplane of the spray drying head.
 23. The spray drier assembly of claim20, wherein the center portion comprises: a first inlet that is adaptedto receive the flow of liquid sample; a second inlet that is adapted toreceive the flow of aerosolizing gas; and an egress port in fluidcommunication with the first inlet and the second inlet, wherein theliquid sample and the aerosolizing gas contact one another upon exitfrom the egress port to form the aerosolized flow of liquid sample. 24.The spray drier assembly of claim 23, wherein the egress port is adaptedto direct the flow of liquid sample and the flow of aerosolizing gas soas to meet and output the aerosolized flow of liquid sample directedparallel to a longitudinal axis of the spray drier assembly.
 25. Thespray drier assembly of claim 23, wherein the portions of the spraydrying head including the first and second inlets are positioned outsideof the first transition zone.
 26. The spray drier assembly of claim 23,wherein the portions of the spray drying head including the first andsecond inlets are positioned within the first transition zone.
 27. Thespray drier assembly of claim 15, wherein the filter is attached to theframe.
 28. The spray drier assembly of claim 15, wherein the filtercomprises: a frame having first and second opposing edges defining anopening; a filter member positioned within the opening; a fold whichbrings the first opposing edges into contact; and a hermetic jointsealing the contacting first opposing edges together such that thesecond opposing edges define an aperture; wherein dried powder and humidair enter the first filter through the aperture.
 29. The spray drierassembly of claim 28, wherein the filter further comprises: firstreinforcing ribs spanning the lateral distance between the firstopposing edges; and second reinforcing ribs spanning the lateraldistance between the second opposing edges.
 30. The spray drier assemblyof claim 15, wherein the collection chamber further comprises a secondportion, separate from the first portion and in fluid communication withthe first portion via the filter, the second portion further containinga desiccant.
 31. The spray drier assembly of claim 15, wherein thecollection chamber further comprises a one-way valve adapted to permitthe humid air to exit the collection chamber.
 32. The spray drierassembly of claim 31, wherein the one-way valve is adapted for fluidcommunication with a vacuum source for urging the humid air to exit thecollection chamber via the one-way valve.
 33. The spray drier assemblyof claim 31, wherein the one-way valve is adapted for fluidcommunication with a filter possessing a Bacterial Filtration Efficiency(BFE) of 10⁶ or more.
 34. A spray drier assembly, comprising: a spraydrying head positioned within an enclosure, the spray drying headadapted to receive a flow of aerosolizing gas and a flow of liquidsample and output an aerosolized flow of liquid sample, the spray dryinghead comprising: an outer wall; a center portion; and a plurality offins extending from the center portion to the outer wall, the pluralityof fins defining a plurality of openings extending through the thicknessof the spray drying head; a drying chamber formed within the enclosure,the drying chamber adapted to receive the aerosolized flow of liquidsample and a flow of drying gas from the spray drying head and outputdried sample powder and humid air; and a collection chamber formedwithin the enclosure, the collection chamber having a integrated filteradapted to separate the dried powder and humid air.
 35. The spray drierassembly of claim 34, the collection chamber further comprising: aninlet port for receiving the dried powder and humid air; an exhaust portfor conveying humid air out of the enclosure; and a first chamber and asecond chamber, the first chamber defined by a first wall of theenclosure and a first side of the filter and the second chamber definedby a second wall of the enclosure and a second side of the filter;wherein the first chamber is contiguous with the inlet port and adaptedto retain the dried powder and allow transmission of the humid air tothe second chamber through the filter; and wherein the second chamber iscontiguous with the exhaust port.
 36. The spray drier assembly of claim35, wherein at least one of the flow of aerosolizing gas, the flow ofdrying gas, and the humid air is adapted to urge the dried powder fromthe drying chamber to the collection chamber.
 37. The spray drierassembly of claim 35, further comprising a one-way valve positioned inthe inlet port, the one-way valve permitting flow of the humid air anddried powder from the drying chamber to the collection chamber andinhibiting flow of the humid air and dried powder from the collectionchamber to the drying chamber.
 38. The spray drier assembly of claim 35,further comprising a one-way valve positioned in the exhaust port, theone-way valve permitting flow of the humid air from the collectionchamber and inhibiting flow of the humid air into the collectionchamber.
 39. The spray drier assembly of claim 35, wherein thecollection chamber further comprises a second portion, separate from thefirst portion and in fluid communication with the first portion, thesecond portion further containing a desiccant.
 40. The spray drierassembly of claim 35, wherein the collection chamber further comprises aone-way valve not positioned at the inlet port or the exhaust port, theone-way valve adapted to permit the humid air to exit the collectionchamber.
 41. The spray drier assembly of claim 40, wherein the one-wayvalve is adapted for fluid communication with a vacuum source for urgingthe humid air to exit the collection chamber via the one-way valve. 42.The spray drier assembly of claim 40, wherein the one-way valve isadapted for fluid communication with a filter with a BacterialFiltration Efficiency (BFE) of 10⁶ or more.
 43. The spray drier assemblyof claim 35, wherein the collection chamber further comprises aplurality of spacers adapted to inhibit contact between the second sideof the filter and the second wall of the enclosure within the collectionchamber.
 44. The spray drier assembly of claim 43, wherein the spacersare selected from the group consisting of ribs and raised bumps.
 45. Aspray drier assembly, comprising: a spray drier assembly body having afirst end and a second end; a source of drying gas in fluidcommunication with the first end of the spray drier assembly body; aspray drying head enclosed within the spray dryer assembly body, thespray drying head comprising an aerosolizer for aerosolizing a flow ofliquid sample received at the spray drying head, wherein the spraydrying head is adapted to output the aerosolized flow of liquid sampleand expose the aerosolized flow of liquid sample to the flow of dryinggas; a filter, disposed between the drying gas inlet and the spraydrying head, a drying chamber positioned between the spray drying headand the second end of the spray drier assembly body, the drying chamberadapted to separate the aerosolized flow of liquid sample into a driedsample powder suspended in humid air; and a collection chamber includinga first filter adapted to separate the dried powder from the humid airand an exhaust port allowing the humid air to exit the second end of thespray drier body; and a second filter, disposed between the drying gasinlet and the spray drying head.
 46. The spray drier assembly of claim45, wherein the aerosolizer provides ultrasonic waves in a wavelengthand frequency sufficient to aerosolize the flow of liquid sample. 47.The spray drier assembly of claim 46, wherein the aerosolizer comprisesone or more of an ultrasonic atomizing transducer, a ultrasonichumidified transducer, a piezo ultrasonic atomizer.
 48. The spray dryerassembly of claim 45, wherein the drying gas travels in a flow to directthe transfer of dried liquid sample or the humid air from the dryingchamber to the collection chamber.
 49. The spray drier assembly of claim45, wherein the flow of drying gas travels through one or more filtersto remove contaminants from the flow of drying gas.
 50. The spray drierassembly of claim 45, wherein the spray drier assembly is adapted forthermal communication with at least one heat source, wherein the atleast one heat source is positioned outside of the spray drier assemblyand wherein the at least one heat source is adapted to heat the spraydrier assembly by electromagnetic radiation.
 51. The spray drierassembly of claim 50, wherein the spray drier assembly is adapted forthermal communication with at least two of the heat sources, wherein thefirst heat source heats the drying chamber to a first temperature andthe second heat source heats the collection chamber to a secondtemperature different than the first temperature.